What the label lists and what reports show
Felodipine side effects
Felodipine's FDA label: “The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache.” FAERS holds 11,323 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,109 reports).
- Generic listed
Check it at the source: the felodipine FDA label on DailyMed (effective August 11, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache.
Percent of Patients with Adverse Events in Controlled Trials* of Felodipine (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)
This table is printed in the Felodipine label published by Yiling Pharmaceutical Inc. of December 29, 2025; the label quoted above does not print one.
| Body System Adverse Events | Placebo N = 334 | 2.5 mg N = 255 | 5 mg N = 581 | 10 mg N = 408 |
|---|---|---|---|---|
| Peripheral Edema | 3.3 (0.0) | 2.0 (0.0) | 8.8 (2.2) | 17.4 (2.5) |
| Asthenia | 3.3 (0.0) | 3.9 (0.0) | 3.3 (0.0) | 2.2 (0.0) |
| Warm Sensation | 0.0 (0.0) | 0.0 (0.0) | 0.9 (0.2) | 1.5 (0.0) |
| Palpitation | 2.4 (0.0) | 0.4 (0.0) | 1.4 (0.3) | 2.5 (0.5) |
| Nausea | 1.5 (0.9) | 1.2 (0.0) | 1.7 (0.3) | 1.0 (0.7) |
| Dyspepsia | 1.2 (0.0) | 3.9 (0.0) | 0.7 (0.0) | 0.5 (0.0) |
| Constipation | 0.9 (0.0) | 1.2 (0.0) | 0.3 (0.0) | 1.5 (0.2) |
| Headache | 10.2 (0.9) | 10.6 (0.4) | 11.0 (1.7) | 14.7 (2.0) |
| Dizziness | 2.7 (0.3) | 2.7 (0.0) | 3.6 (0.5) | 3.7 (0.5) |
| Paresthesia | 1.5 (0.3) | 1.6 (0.0) | 1.2 (0.0) | 1.2 (0.2) |
| Cough | 0.3 (0.0) | 0.8 (0.0) | 1.2 (0.0) | 1.7 (0.0) |
| Rhinorrhea | 0.0 (0.0) | 1.6 (0.0) | 0.2 (0.0) | 0.2 (0.0) |
| Sneezing | 0.0 (0.0) | 1.6 (0.0) | 0.0 (0.0) | 0.0 (0.0) |
| Rash | 0.9 (0.0) | 2.0 (0.0) | 0.2 (0.0) | 0.2 (0.0) |
| Flushing | 0.9 (0.3) | 3.9 (0.0) | 5.3 (0.7) | 6.9 (1.2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedIn controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation. The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving felodipine extended-release tablets, principally for peripheral edema, headache, or flushing. Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (felodipine extended-release tablets, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of felodipine extended-release tablets or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. …
Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective August 11, 2026 (SPL set 0bef7cf2-012b-4804-ac93-0a8b333035db), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,323 reports list felodipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 846 are coded as a death and 5,004 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Felodipine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions